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A Digital Turning Point in Migraine Care: CT-132 FDA Approval to Market is a Win for Patients and Proof that Clinical Evidence Matters

Gil Bashe, Medika Life Editor — Tue, 15 Apr 2025 17:37:21 +0000

Sometimes, when the Food and Drug Administration (FDA) grants marketing authorization for a new treatment, it signals more than regulatory approval, reflecting a moment of transformation for the people who live daily with the disease. This is one of those milestones.

For the more than 37 million Americans who suffer from migraines, the FDA authorization of Click Therapeutics’ CT-132—the first prescription digital therapeutic for the preventive treatment of episodic migraine—is more than a headline. It offers the potential for expanded access, improved quality of life, and the legitimization of digital medicine as a cornerstone of care.

Rewriting the Migraine Narrative

For people living with episodic migraine—those experiencing up to 14 migraine days a month—prevention is critical. Migraine is far more than “just a headache.” It is a neurological disease that can be disabling, impacting work, relationships, and emotional well-being.

According to the American Migraine Foundation, almost 90 percent of people with migraines are unable to work or function normally during an attack. What’s more, only about 12 percent of those with migraines receive preventive treatment—a treatment gap due to side effects, fear, access barriers, or lack of awareness.

“This is where CT-132 emerges as a potential game-changer,” said Click Therapeutics Founder and CEO David Klein in an exclusive comment to Medika Life. “We’re entering a new era of migraine care—where doctors can harness the power of both proven medicines and clinically validated digital therapeutics to meet patients’ urgent needs.”

Data That Delivers

Until recently, the FDA approved most digital health approaches under the device 510K pathway with limited clinical data. FDA marketing authorization for CT-132 was supported by biopharma-like data from the pivotal ReMMi-D randomized controlled trial, in which CT-132 met its primary endpoint by significantly reducing monthly migraine days on top of background pharmacotherapy,

In the bridging study, ReMMiD-C, CT-132 showed similar performance in patients on prescription calcitonin gene-related peptide (CGRP) inhibitors such as Aimovig (erenumab), Ajovy (fremanezumab), Emgality (galcanezumab), Vyepti (eptinezumab), Ubrelvy (ubrogepant), Nurtec ODT (rimegepant), and Qulipta (atogepant). CT-132 is an adjunctive treatment to medication, giving it broad potential use.

CT-132, delivered via a mobile app, achieved statistically and clinically meaningful results in the ReMMi-D pivotal trial. Participants who used the digital therapeutic reported a mean reduction of 3.04 monthly migraine days, compared to just 0.9 days in the sham group (p=0.005). That means real days—at work, with family, outside in the sun—returned to people’s lives.

In a condition where every single migraine-free day matters, the ability to deliver those gains without pharmacological side effects through a smartphone app democratizes access to care. It opens the door to new options, particularly for those who cannot tolerate or access traditional therapies.

“This marks a significant milestone for the more than 37 million adults in the US who live with migraine,” said Shaheen Lakhan, MD, PhD, FAAN, Chief Medical Officer of Click Therapeutics. “CT-132 offers eligible patients a new path to reducing the burden caused by migraine—one they can access anywhere via an evidence-based mobile application on their smartphone.”

Digital Care, Doctor-Led

Importantly, CT-132 does not sideline clinicians—it includes them as front-and-center leaders in care delivery. As a prescription-only digital therapeutic, CT-132 is designed to be used under the guidance of a health provider, adding a new clinical approach to physician-directed personalized care. It enhances—not replaces—traditional physician-patient relationships by enabling clinically validated, behavior-based treatment delivered consistently between visits.

Neurologists and primary care providers who manage migraines now have an evidence-based, non-drug adjustive approach to care, especially to patients who have tried multiple therapies and continue to have breakthrough episodes.

Data is the Gatekeeper

The approval also signals a broader truth long-awaited in digital health: evidence is everything. As digital therapeutics gain traction, the FDA and the medical community are asking for the same rigor as traditional pharmaceuticals.

“For digital health ventures to gain the confidence of regulators, providers, and patients, clinical validation must be central,” said Julien de Salaberry, CEO of Galen Growth. “This approval is a reminder that digital therapeutics can meet gold-standard evidence expectations—and that’s how they earn a place in modern medicine.”

[See Medika Life special report: Consumer HealthTech: A Data-Driven Evolution in Health Engagement]

According to Galen Growth analytics, only 24 percent of digital health companies globally have demonstrated clinical strength through trials or peer-reviewed publications. CT-132 stands out and sets the bar. Generating clinical evidence in digital health has become a marker for success. Galien Growth recently published its landmark analysis of digital health and consumer use, which includes the importance of data for product and category progress.

Slide from the Galen Growth Consumer HealthTech: A Data-Driven Evolution in Heath Engagement Report

A Future Forward

The approval of CT-132 reflects a movement in medicine, reimagining how we define treatment, access, and wellness. It’s a reminder that innovation is not just about what is possible, more importantly, what is proven. As more digital therapeutics enter the pipeline, the CT-132 journey offers a case study of what it takes to cross the threshold from hope to health reality.

This approval to market brings something invaluable to people with migraines: urgency. The ability to be treated anywhere, on their terms, using science-backed interventions, gives people not just fewer migraines but more voice in their care.

This is not just a regulatory milestone. It’s a human one.

[This article is not sponsored or requested by any company. The author has been covering digital health since 1995 and seeks to highlight sector trends. He maintains editorial independence.]

The post A Digital Turning Point in Migraine Care: CT-132 FDA Approval to Market is a Win for Patients and Proof that Clinical Evidence Matters appeared first on Medika Life.

20 People Who are Transforming the Health Ecosystem Through Practical Paths to Apply AI – 2025 Roster

Gil Bashe, Medika Life Editor — Thu, 27 Feb 2025 04:24:08 +0000

As we approach the 2025 HIMSS Global Health Conference, we again highlight key influencers shaping the health system’s future potential by applying AI in practical, transformative ways. Between ViVE in Nashville and HIMSS in Las Vegas, the vanguard of health information management and hospital system global leadership will be visible on the main stage, and they will network in the corridors to share new ideas, writings, and policy predictions. They will look beyond the “cool” and place the operational potential of AI, ChatGPT, and LLMs under a microscope. Medika Life highlights 20 people whose ideas and voices spark conversation each year.

These 20 people are not just theorizing about the whizzbang of hot technology but rolling up their sleeves and demonstrating its value in real-world settings—to improve diagnostic care, access information that can inform treatment, address health inequities, and ensure the financial sustainability of health provider systems that operate on razor-thin margins. Their collective work offers a blueprint for leveraging AI responsibly and (hopefully) ethically, from streamlining hospital operations and enhancing clinical decision-making to revolutionizing drug discovery.

The current AI evolution presents both opportunities and challenges. Health systems face increasing demands, including rising patient expectations and staffing shortages. Implementing AI and large language models (LLMs) can address these concerns by enabling faster and more accurate treatment plans, automating administrative burdens, and personalizing patient care. However, realizing AI’s full potential requires thoughtful application, ethical considerations, and a commitment to addressing disparities.

These 20 champion AI’s practical application, guiding health systems toward innovation without losing sight of humankind’s well-being. They exemplify how AI can enhance rather than replace human expertise—an essential message as we continue to adapt to this rapidly evolving landscape. By following their work, health-sector leaders and innovators can gain invaluable insights into deploying AI for meaningful impact.

Trailblazers Redefining Health Innovation

While many thinkers will wow you with the future possibilities of these technologies, the 20 on this roster demonstrate transformative influence on the future of diagnostics, operational efficiency, and personalized care while emphasizing responsible, ethical implementation. From academia to industry, they provide vital insights and direction into leveraging AI for better health outcomes. Their work underscores AI’s ability to augment human expertise, providing a roadmap for health systems to innovate without losing sight of patient-centric care. Thanks to them and the others appearing on our Medika Life 2023 and 2024 list, we define AI as “augmented implementation” and not artificial intelligence.

How were they selected? They are public-facing, sharing their thoughts in articles, books, keynotes, classroom talks, research papers, and conferences. They willingly share their knowledge with others on their social media platforms. They spark ideas and challenge our current thinking, and these behaviors make them invaluable to the future application of information and its human health impact. Each person appears in hyperlinks so that readers can explore the depth of their contributions and, whenever possible, follow them on their social media platforms.

20 Voices of Influence Shaping AI in Health

Regina Barzilay, PhD

Dr. Barzilay, an MIT professor and MacArthur Fellow, is revolutionizing oncology and drug discovery through AI. Her pioneering work in machine learning has led to breakthroughs in early cancer detection, particularly in breast cancer screening. As co-founder and AI faculty lead of the MIT Jameel Clinic and the AI Cures initiative, she’s spearheading efforts to deploy AI models for cancer risk prediction in hospitals around the globe and accelerate drug development for infectious diseases. Dr. Barzilay’s work in oncology and drug discovery is paving the way for screening policies and new treatments.

Anthony Chang, MD, MBA, MPH, MS

Dr. Anthony Chang, a pediatric cardiologist and founder of AIMed, is a driving force in AI education for health professionals. His book Intelligence-Based Medicine has become a cornerstone text. Dr. Chang’s recent work focuses on developing AI-powered predictive models for pediatric cardiac care and implementing AI solutions to enhance hospital operational efficiency. His annual AIMed conference has become a global platform for sharing cutting-edge AI health innovation.

Karen DeSalvo, MD, MHP

Karen DeSalvo, MD, MPH

Google Chief Health Officer DeSalvo leads initiatives that leverage AI and big data to address critical public health challenges and promote health equity. Her work includes developing AI-driven tools for early disease detection in underserved communities and creating platforms that provide real-time health data analytics for policymakers. Dr. DeSalvo’s leadership in responsible AI use ensures that Google’s health technologies prioritize patient privacy and ethical considerations.

Pamela Davis, PhD

Pamela Davis, MD, PhD

Dr. Davis is a distinguished researcher at Case Western Reserve School of Medicine specializing in AI-driven diagnostics and clinical applications. After 13 years as the Dean of the School of Medicine, she returned to the faculty. Her work centers on predictive algorithms for early disease detection and improved treatment planning. But Dr. Davis is an anomaly to this roster. She has no social media handles and her many published works are not curated carefully. Yet, tracking her contributions shows her depth and national influence on the future of AI in practice. With numerous published studies on AI’s transformative role in health, Dr. Davis continues to shape the future of diagnostic pathways.

David Feinberg, MD, MBA

As Chair of Oracle Health, Feinberg champions using AI and cloud-based technologies to improve health outcomes. He focuses on predictive analytics and data-driven tools that enhance clinical decision-making and streamline hospital operations. His leadership drives innovation in health technology integration. Dr. Feinberg is widely recognized for his transformative leadership as CEO of Geisinger Health, where he pioneered initiatives in population health, precision medicine, and value-based care. His expertise in integrating technology with health-care delivery continues to drive innovation, making digital tools more accessible and impactful for providers and patients.

John Halamka, MD, MS

John Halamka, President of the Mayo Clinic Platform, is a trailblazer in AI-driven health solutions, leveraging data and technology to transform patient care. Co-author of The Digital Reconstruction of Healthcare, Halamka is a leading voice on digital transformation, interoperability, and the ethical use of AI in medicine. His work at the Mayo Clinic focuses on developing scalable digital platforms and AI models to advance diagnostics, remote monitoring, and personalized medicine. With a background spanning emergency medicine, informatics, and policy, Halamka’s insights continue to guide health systems toward a more connected, efficient, and data-driven future.

Taha Kass-Hout, MD, MS

Dr. Taha Kass-Hout, General Manager of Amazon Health AI, is a pioneer in leveraging artificial intelligence to drive advancements in healthcare delivery. With a background in clinical practice, public health, and digital innovation, he leads initiatives that harness AI for improved diagnostics, care management, and population health outcomes. Previously, as the first FDA Chief Health Informatics Officer, he championed data-driven approaches to public health. His leadership at Amazon drives scalable, data-driven health models that integrate machine learning with real-world applications, positioning him as a key influencer in the future of AI in health.

Isaac Kohane, MD, PhD

Dr. Kohane, Chair of the Department of Biomedical Informatics at Harvard Medical School and co-author of The AI Revolution in Medicine: GPT-4 and Beyond, is a leading authority on the intersection of AI and clinical care. His research focuses on using machine learning for precision medicine and improving electronic health records. Dr. Kohane has been instrumental in developing AI models that enhance diagnostic accuracy and patient outcomes. His recent work explores the potential of LLMs, such as ChatGPT, in clinical decision-making and patient engagement.

Daniel Kraft, MD

Dr. Daniel Kraft is the founder of Exponential Medicine and a visionary in personalized medicine approaches. He’s an inventor, a former F-16 flight surgeon, and always ready to champion others’ bold ideas. Dr. Kraft explores how AI can transform health delivery and disease prevention. Dr. Kraft’s recent initiatives focus on AI-powered tools for early diagnosis and patient engagement. His next chapter includes the very successful NextMed Health and the evolution of Exponential Medicine. NextMed Health 2025 will be held in San Diego on March 30 and April 2, 2025.

Tom Lawry

Tom Lawry, soon to be the author of his highly anticipated new book Health Care Nation: The Future Is Calling, and It’s Better Than You Think, may redefine the intersection of technology and patient care. Already renowned as the author of Hacking Healthcare, Lawry has built a reputation as a leading AI strategist who advises organizations on integrating cutting-edge AI solutions to boost operational efficiency. His former role at Microsoft as Director for AI for Health and Life Sciences, Director of Worldwide Health, and Director of Organizational Performance for the company’s first health incubator cements his standing as a trailblazer in health innovation. He’s almost always a keynote favorite at conferences such as HLTH and HIMSS.

Fei-Fei Li, PhD

Dr. Fei-Fei Li is a strong advocate for diversity and inclusion in AI, emphasizing ethical considerations and societal impact. She co-founded AI4ALL, a nonprofit dedicated to increasing diversity in artificial intelligence, and has played a pivotal role in shaping policies for responsible AI development. Her leadership continues to influence the global AI landscape, bridging technology with human values.

Vivian Lee, MD, PhD. MBA

Vivian Lee, MD, PhD, MBA

Dr. Lee, author of The Long Fix, is a pioneering health tech executive driving data-driven health transformation. Her recent work includes developing AI-powered platforms for value-based care models and implementing predictive analytics to reduce hospital readmissions. Dr. Lee’s initiatives as former president at Verily Life Sciences focused on leveraging AI to optimize care delivery across diverse populations.

Peter Lee, PhD

As Corporate Vice President of Microsoft Health, Dr. Peter Lee spearheads initiatives that apply AI to solve complex health-sector challenges. His recent projects include developing AI models for precision medicine and creating cloud-based solutions for health data interoperability. In his role, Dr. Lee seeks to solve complex health-sector challenges by integrating cutting-edge technology with practical healthcare applications.

John Nosta

John Nosta has earned his place as a top influence in the AI landscape—particularly in discussions surrounding ChatGPT and large language models—due to his visionary insights and ability to demystify complex technological innovations. His thought leadership bridges the gap between cutting-edge AI research and practical, real-world applications, making the transformative potential of these tools accessible to a broad audience. By articulating AI’s promise and ethical challenges, Nosta fosters a balanced dialogue that drives the industry forward. His forward-thinking perspective and engaging commentary not only illuminate the evolving impact of AI on various sectors but also inspire both startups and established companies to reimagine the future of technology. Nosta has an upcoming book that is expected to drop sometime in fall 2025.

Ziad Obermeyer, MD

Ziad Obermeyer, MD, is the Blue Cross of California Distinguished Associate Professor of Health Policy and Management at the UC Berkeley School of Public Health, researching the intersection of machine learning, medicine and health policy. His work has exposed biases in clinical algorithms and highlighted disparities in care delivery. As a co-founder of Nightingale Open Science, he promotes data transparency and collaboration to advance medical AI. His contributions are reshaping predictive analytics and decision-making in healthcare. Before his full-time career in emergency medicine, he consulted pharmaceutical and global health clients at McKinsey & Co. in New Jersey, Geneva, and Tokyo.

Neal Patel, MD, MPH

As the Chief Information Officer for Health IT at Vanderbilt University Medical Center (VUMC), Dr. Patel leads the integration of advanced technologies into health delivery. With more than two decades of experience in HIT, Patel has been instrumental in computerized physician order entry systems and electronic health records to enhance clinical and quality processes. He focuses on translating VUMC goals into informatics strategies, optimizing patient care, and improving safety and services across the care continuum. Dr. Patel’s work underscores the transformative potential of AI and LLMs in the provider system.

Kyu Rhee, MD, MPP

As Senior Vice President at CVS Health, Rhee leads initiatives that leverage AI for health equity and personalized care. His recent projects include implementing AI-driven health risk assessments in underserved communities and developing machine learning models to predict medication adherence. Through his leadership, CVS has deployed AI-powered virtual care solutions expanding access to preventive services and helping to close care gaps while improving outcomes for diverse patient populations.

Nigam Shah, MBBS, PhD

Dr. Shah, a professor at Stanford University, specializes in applying AI to clinical workflows and electronic health records. His recent work includes developing AI models for real-time clinical decision support and creating algorithms to identify patients for clinical trials. He has published extensively in peer-reviewed journals on machine learning applications in healthcare and co-authored chapters in Artificial Intelligence in Medicine. Shah also leads Stanford’s Center for Biomedical Informatics Research, advancing research on AI’s role in population health and precision medicine.

Eric Topol, MD

Dr. Eric Topol is not just “a” trailblazer in digital medicine. He will likely be among those acknowledged singular voices bridging the possible with the practical. His groundbreaking work has consistently pushed the boundaries of health innovation. Dr. Topol redefined patient empowerment with his seminal book The Patient Will See You Now. He transformed the traditional healthcare model, advocating for a future where technology facilitates personalized, proactive care. As the author of Deep Medicine, he continues to champion the integration of AI in health, exploring its potential to revolutionize patient care. Dr. Topol’s visionary contributions and commitment to merging clinical expertise with cutting-edge technology have established him as a guiding voice at the intersection of care and innovation, making him a standout influencer in AI applications.

Hal Wolf, III, FHIMSS

Harold (Hal) Wolf is the president and CEO of HIMSS, a global advisor and thought leader supporting the transformation of the health ecosystem through information and technology. If health-related smart technologies such as AI, ChatGPT, GenAI, and LLMs have a central home to discuss policies and implementation, it is HIMSS. Hal shepherds the world’s health information management community. While his staff advance science and policy, championing implementation throughout the ecosystem. Wolf and HIMSS are where theory meets action. Wolf is far more than a leader of a global society of import; he is the community’s ambassador to NGOs, governments, and industry.

A powerful exchange with Tom Lawry, author of the bestseller Hacking Healthcare and an upcoming book on the nation’s health system, and Medika Life Editor-in-Chief Gil Bashe on the power of information and AI to transform health. Microsoft sponsored the conversation.

The Rise of Generative AI in Digital Health: Key Insights from Galen Growth

Beyond tracking the 20 listed in the year’s people to watch and the previous two years, following the Galen Growth executive briefing Generative AI in Digital Health – Hype or Reality? The report is a must-read for AI, ChatGPT, and LLM professionals. It reveals how nearly 4,000 digital health ventures leverage AI, with 2% focused on generative AI. Notably, 27% of these applications enhance health management, and over 330 AI-driven ventures have partnered with health systems in the past five years. This report offers critical insights into AI’s growing impact on digital health innovation.

Acknowledgments

I thank my Medika Life colleagues, including Drs. Robert Turner, Jeff Livingston, Hesham A. Hassaballa, Patricia Farrell, and Michael Hunter, whose commitment to public health information inspire. I am also grateful to the many sector professionals I engage at events such as CNS Summit, DHAI, HIMSS, HITLAB, HLTH, and ViVE—people who generously share perspectives and contribute invaluable recommendations. A shout-out to Christina Raish, our new associate editor at Medika Life, for her support in making this feature possible.

Special recognition goes to those who have appeared on past Medika Life lists and remain engaged in advancing health and well-being. Their commitment to meaningful change is commendable to individuals and the planet. These trailblazers continue to push boundaries, demonstrating an unwavering dedication to improving lives.

Since the dawn of civilization, humanity has been awed and challenged by technological progress—from the mastery of fire to artificial intelligence. Each era, from the Stone Age to the Iron Age and now the Information and Cognitive Age, has demanded careful consideration of how best to harness innovation. Today, as we navigate the era of “thinking” technologies, one truth remains unchanged: the power of human insight, courage, and empathy must guide progress.

—Gil Bashe, Editor-in-Chief, Medika.Life

Remember to Follow the Voices of Influence from our 2023 and 2024 Rosters:

Medika’s Top 20 AI Voices to Watch. Follow These Experts as They Demystify AI and Its Future

As AI and LLMs Supercharge Digital Health Possibilities – Here Are Medika’s Top 20 ’24 Influential Voices to Follow

Spot a broken link, typo, forgotten degree, or name misspelled?

Oops! Apologies! While care has been taken in compiling this list and adding social media links, things go wrong: a name is misspelled, a link is broken, or an incorrect social media handle is listed. Please do get in touch to address typos, amendments, or omissions by reaching gil.bashe@medika.life.

Thanks in advance and be healthy!

The post 20 People Who are Transforming the Health Ecosystem Through Practical Paths to Apply AI – 2025 Roster appeared first on Medika Life.

Forget Hype – Digital Therapeutic Data Show the Category Can be Held to High Clinical Standards

Gil Bashe, Medika Life Editor — Wed, 04 Sep 2024 19:31:50 +0000

The announcement from Click Therapeutics that its digital therapeutic CT-132 met its primary endpoint in the ReMMi-D pivotal trial is a key development for migraine treatment and the digital health community. The study’s results point to the potential of digital therapeutics as a complement to existing medications and as a scientifically validated option capable of improving patient outcomes in complex conditions like migraines.

Scientific Progress for Patients and a Category

At the core of the ReMMi-D trial was the evaluation of CT-132, a prescription digital therapeutic, for the preventive treatment of episodic migraine. The study included 568 participants and was designed with the scientific rigor traditionally associated with pharmacological interventions. The results were compelling: patients using CT-132 experienced a reduction during three-monthly migraine days by the end of the 12-week treatment, a key metric in migraine management.

More than reducing the frequency of migraines, CT-132 showed improvements in patient-reported outcomes related to quality of life and disability, such as the Migraine-Specific Quality-of-Life Questionnaire and the Migraine Disability Assessment. These metrics matter because migraine is a neurological condition that disrupts life activities, affecting employment and social relationships. For the millions of people who have unpredictable and disabling migraines, improvement can have profound quality of life.

According to a statement by Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics:“Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in 2 separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure. We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”

Building on Existing Treatment Possibilities

Migraine remains one of the most debilitating neurological conditions, affecting more than 37 million Americans. Despite pharmacological treatment advances, many people still find their lives shaped by frequent, unexpected, debilitating episodes. Existing medications can be effective, yet they don’t work for everyone and at every instance. Some patients struggle with adherence, side effects, or simply the anxiety around consistent relief.

CT-132 holds the potential for a new kind of intervention. Delivered by a smartphone, this digital therapeutic is designed to work alongside patients’ existing medications, augmenting their current treatments rather than replacing them. Notably, the trial was designed to evaluate CT-132 in patients already using standard migraine medications. Data from the trial points to the efficacy of CT-132 as a stand-alone intervention and suggests an additive benefit when combined with existing FDA-approved pharmacological treatments.

This approach is key to conditions like migraine, where no single treatment is universally effective. For many people, managing migraine calls for a combination of therapies—some interventional, others pharmacological, and still some behavioral. CT-132’s success demonstrates that digital therapeutics have the potential to be additive to that combination, helping people regain control over their condition.

A Potential Step Forward for Digital Health

The results of this trial are even more noteworthy for an entire sector because CT-132 is one of the first digital therapeutics to be evaluated with the same rigorous standards typically applied to pharmaceutical interventions. The randomized, double-masked, controlled study design is a gold standard in clinical research, and Click Therapeutics has brought that level of precision to the digital health category.

Stan Kachnowski, PhD, MPA, founder of HITLAB and a prominent figure in health informatics, has also echoed the importance of this transformation, stating previously that “The convergence of digital therapeutics and traditional healthcare is one of the most promising avenues for improving patient outcomes. Clinical data helps substantiate the effectiveness of digital interventions, paving the way for broader adoption in complex diseases like migraine.”

Digital health has often been touted for its innovation and potential, but the field has faced great skepticism around its ability to deliver scientifically proven results. The CT-132 trial is an answer to those on the sidelines, demonstrating how digital therapeutics—with ample clinical data—can improve people’s outcomes. The nearly 100% completion rate of daily tasks in the trial speaks to the potential for sustained patient engagement, an essential factor in the long-term success of any therapeutic intervention.

Recent FDA guidance on Prescription Drug Use-Related Software (PDURS) opens the door to a new treatment category combining digital and pharmacological interventions. The data from CT-132 adds weight to this model, opening the wide door to showing how digital therapeutics can support existing treatments and may offer added measurable benefits.

Photo Credit: Author – Two years ago, the author heard Click Therapeutics CEO David Klein declare on the mainstage of HITLAB in a fireside chat with Stan Kachnowski, PhD, MPA, that digital health companies need to be held to a higher standard – similar to biotech companies – when it comes to producing clinical data. Klein and Click have lived up to that mainstage pledge.

What This May Mean for Consumers

The implications of this study are significant for people and physicians who treat migraines. Beyond diagnosis, migraine is more than a medical condition—its constant presence dictates when and how people can work, study, and socialize. The Click Therapeutics data suggest a new avenue of relief that is readily accessible and shows the potential to reduce the burden of migraine in daily life.

In digital health, data is key. Julien de Salaberry, CEO and founder of Galen Growth has often emphasized: “Data is the defining difference in how we can transform digital health into a category with the same rigor and trust as traditional biopharma.” This sentiment captures the critical role that data plays in not just validating the efficacy of digital therapeutics but also in driving their adoption and integration into mainstream healthcare.”

Moreover, the trial was designed to be used alongside existing medications, which could assist people who feel they have already exhausted their treatment options. This is important for those who experience ongoing migraine symptoms despite the use of preventive, newer migraine medications. Digital therapeutics with demonstrated data may provide an added layer of treatment that doesn’t require the introduction of more drugs or drug-related side effects.

Future of Migraine Treatment and Digital Health

This trial’s success is more than a win for Click Therapeutics—it signals what’s possible in digital health. In demonstrating that a digital intervention can demonstrate clinical outcomes in a condition as debilitating as migraine, CT-132 may have set the bar for digital therapeutics and offers private and public payers reason to become excited about the category.

As more digital therapeutics enter the clinical landscape, their ability to integrate with and enhance traditional treatments will be crucial to their success. This trial shows that digital solutions can do more than provide “feel-good” supplementary support—they can drive measurable improvement in patient health. The data are essential to showing that hype cannot be a clinical option; digital health must deliver high evidence before being considered a serious patient option.

By setting this new precedent for clinical validation, Click Therapeutics has contributed to a more significant shift in how we think about digital health. It’s not just about innovation for its own sake—it’s about how technology can change how we manage health when designed with scientific rigor and people’s needs in mind.

The post Forget Hype – Digital Therapeutic Data Show the Category Can be Held to High Clinical Standards appeared first on Medika Life.

As AI and LLMs Supercharge Digital Health Possibilities – Here Are Medika’s Top 20 ’24 Influential Voices to Follow

Gil Bashe, Medika Life Editor — Wed, 31 Jul 2024 01:53:03 +0000

For many, the term “artificial intelligence” evokes concerns about job displacement or dispassionate decisions made absent human touch. However, it’s crucial to recognize that AI is not just a job eliminator but also its creator. The technology has the potential to generate new, potentially higher-paying job opportunities, making those with AI application knowledge invaluable assets in a sector driven by ideas and innovation. It also opens the possibility of ensuring racial and economic disparities are not overlooked by embedded human oversight.

Technological advances, including AI, are like fire—destructive and essential. Our mastery of fire has been vital to industrial and technological progress, from smelting iron to the steam engine to sterilizing food and medical instruments. But, unchecked, fire is a destructive, societal danger. Similarly, AI can be a force for positive change, but it requires a positive perspective and responsible use to avoid potential dangers and greater socio-economic disparities.

By tapping into AI’s potential, we can create a future where human ingenuity and machine learning work together to improve the well-being of people and the planet. For instance, AI can assist in medical diagnoses, climate change predictions, and disaster response, among other areas. But to make that possible, we will need the courage and curiosity to see AI as humanity’s partner rather than an unwelcomed competitor – to leverage its strengths to complement our own.

Language matters, so we might be better off and more equipped to apply smart technologies by thinking about AI not merely as “artificial intelligence but, at the same time, “augmented implementation.”

AI is not theoretical. It’s already transforming drug research and discovery and patient care delivery. From the research bench to the patient bedside, augmented implementation accelerates the discovery of new drugs and optimizes clinical trials, assigning the right patients to the right protocol. In hospitals, AI enhances resource allocation, accelerates clinical decision-making, personalizes patient care, automates administrative tasks such as billing and scheduling follow-up appointments, and tracks supply-chain necessities to avoid drug shortages. These implementation advancements result in better patient outcomes, reduced health costs, and a more effective care delivery system.

So, what is the problem? It seems evident that embracing these information technologies can make us smarter and faster – even fail smarter and faster. We don’t even need to know coding. Large language models (LLMs) with the proper prompts can generate code based on a natural language description of the desired functionality.

Perhaps the problem isn’t the technology; it’s humanity. While most believe that humanity will triumph over tech, people’s fears translate into “pump the breaks” reflexes. But go slow quickly also ensures guardrails are in place for its appropriate use. These transformative informational technologies are happening; now it’s a question of protecting people’s privacy and well-being, using these platforms ethically and responsibly, and keeping our eye on the prize – people’s healthy lives and the planet’s sustainable future.

20 AI/ChatGPT/LLM Champions to Follow

Once again, selecting only 20 thoughtful pathfinders for this listing was a challenge. There are thousands of people writing, speaking, and commenting about AI. It remains a hot topic and is always trendy. This list is not an exclusive roster of people speaking about or explaining AI possibilities. Those that do appear are key voices of influence at the frontlines of AI, GenAI, ChatGPT and LLMs and are boldly guiding the health sector and other related industries to adapt to these technologies ethically and practically. There is no turning back! For that reason, it is important to follow their social posts, speeches, and writings. They are consultants, physicians, policymakers, teachers and theorists. What they say and write should inform opinions and directions. Follow them and get smarter faster or fail slowly.

On this list, you will notice several differences from our last roster. First, we begin with including an LLM model we have been tracking and recommend following closely. Dave AI was the topic of a previous Medika Life article and is a role model for those interested in the potential of LLM technology to augment the patient-care team’s abilities and desire to help and heal. Dave AI offers patients WAZE-AI-like information support.

We have also included an organizational policy leader to close the list—Hal Wolf, President and CEO of HIMSS. We have interviewed Hal before, and his global community, nearing 40,000 members, comprises health leaders and government representatives who are setting the parameters for how these smart technologies can be used wisely.

Acknowledgments

Special appreciation to Medika Life colleagues such as Drs. Robert Turner, Patricia Farrell, and Michael Hunter, who inspire and the many others from numerous circles I meet at meetings CNS Summit, DHAI, HIMSS, HITLAB, HLTH, and ViVE and who share their thoughts and contribute recommendations. Many who appeared on the initial list of global voices keep in touch and share news of sector colleagues who are in the thick of the conversation. Special acknowledgment to people who appeared on previous Medika Life lists and continue along the path to improve the well-being of people and the planet. These exemplary people are dedicated to improving people’s health and we applaud their efforts to make a difference.

Since the dawn of time, people have been in awe and fear about advances made in times marked by technologies—from fire to AI: the Stone Age, Iron Age, and now, today’s Information and Sustainability Age. Humanity must decide how best to deploy these transformative “thinking” technologies. The emphasis on objective and expansive (courageous) “thinking”—the human touch—remains constant.

Gil Bashe, Editor–in-Chief, Medika.Life

AI and ChatGPT Global Voices of Influence

Image created by Dalle 3.

Here is our Medika Life roster of 20 people to follow in alphabetical order—all-important voices to track and learn from in the coming years. We have included links to the social media platforms and bios wherever available.

Follow these Voices of Influence—they are accessible leaders who write and speak on the future of how AI, ChatGPT, GenAI, and LLMs will be essential to health system transformation and the future of care delivery.

Dave AI – Cancer Mentor

Dave AI

Dave is the world’s first LLM conversational AI oncology mentor for cancer patients, bringing a new level of support for cancer patients and their families and trained on billions of unique data points and anonymized real-world patient journey information accumulated during eight years on the Belong Life platform. Learn how LLMs make a difference for patients and the care team, “Meet Dave” and see the practical possibilities and potential of LLMs.

Anima Anandkumar

Anima Anandkumar, PhD

Anima Anandkumar is a Bren Professor at Caltech. Her work developing novel artificial intelligence algorithms enables and accelerates scientific applications of AI, including scientific simulations, weather forecasting, autonomous drone flights, and drug design. Anandkumar is a fellow of the ACM, IEEE, Schmidt Science, Guggenheim and Alfred. P. Sloan Foundations.

Anima Anandkumar, PhD

Brian Anderson, MD

Dr. Brian Anderson is the Chief Executive Officer and Co-Founder of the Coalition for Health AI (CHAI). He leads a national coalition developing technical standards and best practices for MLOps, including governance, testing, evaluation, and monitoring in Health AI Assurance Labs. Dr. Anderson led the Informatics and Network Medicine Division at Athenahealth, where he launched a new approach to clinical decision support leveraging machine learning models.

Pascal Bornet

Pascal Bornet is an award-winning expert, author, keynote speaker, influencer, and thought leader in artificial intelligence. He has received multiple technology and artificial intelligence awards. Various research and consultancy firms rank him as one of the top 10 global experts in AI and Automation, and he was awarded Global Top Voice in Tech in 2019. He is the author of the best-seller and first reference book on Intelligent Automation.

Lex Fridman, PhD

Lex Fridman, PhD, is a Russian-American computer scientist, podcaster, and artificial intelligence research scientist at the Massachusetts Institute of Technology on computer vision and autonomous vehicle systems, among other areas of specialty. Fridman also hosts the “Lex Fridman Podcast,” a popular podcast and YouTube series.

Mo Gawdat, MBA

Mohammad “Mo” Gawdat is an Egyptian entrepreneur and writer. He is the former chief business officer for Google X and the author of the bestselling business books covering life and technology: Solve for Happy and Scary Smart – The Future of Artificial Intelligence and How You Can Save Our World. His premise is critical – “Humans design the algorithms that define the way that AI works, and the processed information reflects an imperfect world.”

Aneesh Chopra, MPP

Aneesh Chopra is the Chief Strategy Officer of Arcadia, a health data platform that acquired CareJourney, the company he co-founded in 2014. Aneesh served as the first United States White House Chief Technology Officer during the Obama Administration and authored “Innovative State: How New Technologies Can Transform Government.‘ When it comes to policy and smart tech applications, he’s at the forefront of the conversation.

Eric Horvitz, MD

Microsoft’s Chief Scientific Officer and an early AI champion for health and medicine going back many years, Dr. Eric Horvitz is among the founders and funders of Stanford’s 100-year longitudinal study of the impact of AI on Society. Dr. Horvitz is known for his contributions to AI theory and practice, with a focus on principles and applications of AI amidst the complexities of the open world.

Andrej Karpathy, PhD

Andrej Karpathy was the senior director of AI at Tesla, where he led its computer vision team in the development of the Tesla Autopilot. He championed its neural network training, the science of “making it work, ” and deployment. His PhD focused on convolutional/recurrent neural networks and their applications in computer vision, natural language processing, and their intersection – his adviser was Fei-Fei Li at the Stanford Vision Lab, who also makes this list of 20 people to follow. He also did a stint at OpenAI.

Tom Lawry

Tom Lawry is a leading AI transformation advisor to health and medical leaders globally, a top keynote speaker, and best-selling author of Hacking Healthcare – How AI and the Intelligent Health Revolution Will Reboot an Ailing System. Now the managing director of Second Century Tech, he is a former Microsoft leader who served as National Director for AI for Health and Life Sciences, Director of Worldwide Health, and Director of Organizational Performance for the company’s first health incubator. Prior to Microsoft, he was Senior Director at GE Healthcare, the founder of two venture-backed healthcare software companies, and a health-system executive.

Fei-Fei Li, PhD

Dr. Fei-Fei Li is the inaugural Sequoia Professor in the Computer Science Department at Stanford University and Co-Director of Stanford’s Human-Centered AI Institute. She was the Director of Stanford’s AI Lab from 2013 to 2018 and mentored others appearing on this Medika Life Top 20 list of AI voices to follow.

Berci Mesko, MD, PhD

Bertalan Meskó, PhD, is known as “The Medical Futurist” and the Director of The Medical Futurist Institute. He analyzes how science fiction technologies can become a reality in medicine and healthcare. Dr. Mesko’s writings are must-reads—he provides incredible practical knowledge on how AI will transform the health sector. He holds a PhD in genomics and is an Amazon Top 100 author. His book, “The Future of Medicine,” outlines his journey as a medical futurist.

Allie K. Miller

Allie K. Miller was the Global Head of Machine Learning Business Development for Startups and Venture Capital at Amazon (AWS), advising the world’s top machine learning researchers, founders, and investors. She was the youngest-ever woman to build an artificial intelligence product at IBM, spearheading product development across computer vision, conversation, data, and regulation for thousands of companies. Allie continues to explore how this technology will impact workflow.

Andrew Ng, PhD

Dr. Andrew Ng is a globally recognized leader in AI. He is the Founder of DeepLearning.AI, the Founder and CEO of Landing AI, the General Partner at AI Fund, the Chairman and Co-Founder of Coursera, and an Adjunct Professor at Stanford University’s Computer Science Department.

John Nosta

John Nosta is a cutting-edge thinker and speaker in the world of technology, science, medicine, and innovation. He is globally recognized among the foremost voices constantly pushing the envelope on how AI and ChatGPT will transform health settings and workflow. Nosta is a nonstop power thinker (and contrarian) and has more than 500 articles published on innovation topics. His writings on Psychology Today chronicle “The Cognitive Age.” John is someone who challenges the status quo. As a creative thinker; he’s also been the spark behind several multi-billion health products improving and saving lives.

Tam C. Nguyen

Tam Nguyen holds multiple appointments, including Associate Professor at Melbourne Medical School and Deputy Director of Research at St. Vincent’s Hospital Melbourne. He has more than 20 years of experience in clinical trials, health and medical research, and research management, including tertiary teaching hospitals, medical research institutes, and universities across Australia. He is applying smart technologies to learn and engage faster. He is the co-editor of the recent book Artificial Intelligence in Medicine (Springer).

Ziad Obermeyer, MD

Ziad Obermeyer, MD, is the Blue Cross of California Distinguished Associate Professor of Health Policy and Management at the UC Berkeley School of Public Health, researching the intersection of machine learning, medicine and health policy. Before his full-time career in emergency medicine, he consulted pharmaceutical and global health clients at McKinsey & Co. in New Jersey, Geneva, and Tokyo.

Brian Roemmele

Brian Roemmele is an author, scientist, researcher, analyst, connector, thinker, and doer. Brian became an early adopter of AI and neural networks and pioneered Prompt Engineering technologies and techniques to understand and extract information from AI platforms. He’s also a bit of a pop icon, and his works range from smart tech to how to apply Pokémon for customer acquisition.

Stela Solar

Stela Solar is the Inaugural Director of Australia’s National AI Centre, hosted by CSIRO. The Centre’s mission is to accelerate positive AI adoption and innovation that benefits businesses and the community. Currently, Stela also serves as Co-chair of the Commonwealth AI Consortium.

Hal Wolf, III

Harold (Hal) Wolf III

Harold (Hal) Wolf is the president and CEO of HIMSS, a global advisor and thought leader supporting the transformation of the health ecosystem through information and technology. If health-related smart technologies such as AI, ChatGPT, GenAI, and LLMs have a central home to discuss policies and implementation, it is HIMSS. Hal shepherds the world’s health information expert community, and his staff advances the science and policy championing implementation throughout the health ecosystem. Wolf and HIMSS are where theory meets action.

AI and LLMs are infusing digital health with new relevance and practical value for drug development researchers and hospital systems. Galen Growth hosted this conversation with industry leaders John Nosta, Gaye Bok, Sara (Hupp) Schmachtenberg, Ph.D., and Lawrence Wurtz.

Spot a broken link, typo, forgotten degree, or name misspelled?

Thanks in advance and be healthy!

The post As AI and LLMs Supercharge Digital Health Possibilities – Here Are Medika’s Top 20 ’24 Influential Voices to Follow appeared first on Medika Life.

HITLAB Innovation June Summit is a Power Hit for Digital Health Change Agents

Gil Bashe, Medika Life Editor — Wed, 28 Jun 2023 15:17:45 +0000

Digital health is driven by collaboration and fueled by patient need, talent and capital. To fulfill its most significant potential, it calls upon the diverse sectors of the fragmented health ecosystem to help it navigate the peaks and valleys of private equity, science and payer skepticism. It must demonstrate value and brand traction if it survives the birthing-to-market process.

Along that difficult road is support – a place of respite from the complex environment innovators face – the community of HITLAB, the Health Innovation Technology Lab. HITLAB is a leading academic research institution focused on improving global healthcare through innovation and technology and housed within Columbia University in New York City and Chaired by Stan Kachnowski, Ph.D. MPA, HITLAB has become a haven for health, technology, and design champions to find common ground.

“The HITLAB Innovation Summit is a dynamic platform where healthcare leaders, entrepreneurs, and innovators come together to forge groundbreaking solutions,” reflects Dr. Kachnowski. “It fosters collaboration, sparks creativity, and drives healthcare transformation through the power of technology and innovation.”

HITLAB academic roots at Columbia set a tone for research and training. New York City has emerged as a hub for digital health innovation. It is home to more and more startups drawing on the resources of the nation’s financial capital, a close connection to academic medical centers and talent. The Big Apple – like Bean Town Boston – is a strategic epicenter to explore how emerging technologies such as augmented intelligence (AI) and virtual reality (VR) find a meeting point with telehealth and remote patient monitoring through rigorous research, analysis, and design thinking.

Centered Around Cutting-Edge Solutions

At its annual HITLAB Innovators Summit 2023, conversations center around cutting-edge solutions for the digital health community to overcome social determinants of health and unite disparate hospitals’ information systems. The gathering is a digital health sector roadmap to advance health access, address challenges, and improve patient outcomes.

Attendees of this intimate Summit that combines keynotes, panel conversations and scheduling networking are fans!

“The HITLAB Innovation Summit is a game-changer for the healthcare industry. The convergence of technology, innovation, and expertise creates an electric environment that fuels groundbreaking ideas and fosters meaningful collaborations,” says John Anderson, chief technology officer HealthTech Innovations.

While other like-forums have evolved into co-counseling sessions on how to survive EHRs and the heavy life to onboard the 500-pound EPIC gorilla, attendees at HITLAB also learn about “EPIC envy” – where small and community health centers that don’t have the resources to afford this state-of-the-art software find alternative paths tapping into technologies to piece together other ways to track patient care and outcomes.

Also, in hearing from major biopharmaceutical companies such as Merck, Novo Nordisk, and others, digital health innovators can reflect on the importance of ample science to shift the conversation from hype to hope and fact-based cautious optimism. In turn, big pharma share openly on the main stage how science alone – absent of technology – can fall short in meeting patient information, adherence and care needs.

As in previous years, the HITLAB Innovation Summit 2023 brings together experts across the health innovation ecosystem, including clinical trials, pharma, private equity, public health, engineering, design, and data science. The diverse community is seeking solutions that integrate health tech – digital therapeutics, health information, and smart devices meaningfully. The gathering’s success lies in bridging the gap between patients, payers, product innovators, policymakers and providers. It enables these communities to connect and accelerate practical solutions that can be implemented in real-world settings.

Presenters are Category Leaders

Presenters are bold and blunt. From Bill Taranto, President, Merck Global Health Initiative Fund, to Dr. David Berger, CEO, SUNY Downstate Medical Center, to David Klein, CEO and Co-founder, Click Therapeutics, to Tim McCarthy, Head of Digital Sciences & Translational Imaging, Pfizer and representatives from public health, venture capital finance, legal and regulatory; the three-day gathering offers a bolus of category knowledge.

“The time is now for this space – a revolution in medicine is about to happen that will shift care to center around patients,” emphasizes Click Founder and CEO David Klein.

Klein was among the key voices discussing integrating therapeutic choices and that physicians would look more holistically in treating patients with drugs, digital therapeutics and behavioral guidance – focusing on people care satisfaction. Digital therapeutics must model its efforts akin to biotechnology driven by evidence-based clinical outcomes looking beyond the 510K regulatory milestone for approval.

Actionable Insights

The insights shared will guide business planning decisions among newcomers and veterans to the category. Among the noted attendees at this year’s HITLAB Innovation Summit is Amir Kishon, Ph.D., CEO of Twig Health. Kishon was among the early pioneers in the sector.

“Healthcare as a regulated industry is somewhat apprehensive about innovation. It is in its DNA. Digital health is challenging this predisposition and the question I ask myself is when this industry will tip to appreciate that innovation is a friend. We are getting there,” notes Kishon.

The program conducts studies and clinical trials that set out the scientific methodology to assess digital health interventions’ efficacy, usability, and safety. It’s now acknowledged that Food and Drug Administration 510K approval to market for digital applications and therapies is a necessary regulatory threshold; the barrier to success is convincing science as a solid foundation for access that requires payer and provider support and a clear pathway to reimbursement.

Bottomline – it’s about reimbursement and ease of use. In the session What’s Needed for Sustainable Adoption of Digital Health American Medical Association Vice President for Digital Health Strategy, Meg Baron, offered very clear insight into how digital health enterprises can better integrate into the physician’s workflow – the “return on health” to show value.

Beyond the Summit, HITLAB promotes entrepreneurship and innovation in the digital health space. HITLAB is multi-faceted – professional development, accelerator and crowd-sources community for startups and early-stage companies, helping them navigate the complex healthcare landscape, access funding opportunities, and refine their product or service offerings.

In incubating promising ideas, HITLAB fuels the growth of the digital health ecosystem, fostering the development of transformative solutions that address unmet needs and drive positive change. Put the fall meeting on your calendars!

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